Evidence map›Paper›PMID 33763789›Full record

Trial reportBreast cancer research and treatment2021

Eribulin-based neoadjuvant chemotherapy for triple-negative breast cancer patients stratified by homologous recombination deficiency status: a multicenter randomized phase II clinical trial.

Norikazu Masuda, Hiroko Bando, Takashi Yamanaka, Takayuki Kadoya, Masato Takahashi, Shigenori E Nagai, Shoichiro Ohtani, Tomoyuki Aruga, Eiji Suzuki, Yuichiro Kikawa and 10 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research and treatment, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
1.5field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Pooled it
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  5. Therapeutic Potential of Metal-Based and PARP Inhibitor Chemotherapy forInternational journal of molecular sciences · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 13 institutions in 1 country.

Norikazu MasudaDepartment of Surgery, Breast Oncology, NHO Osaka National Hospital, 2-1-14 Hoenzaka, Chuou-ku, Osaka, Japan. nmasuda@alpha.ocn.ne.jp.ORCID http://orcid.org/0000-0002-7302-0278
Hiroko BandoBreast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.
Takashi YamanakaBreast and Endocrine Surgery, Kanagawa Cancer Center, Kanagawa, Japan.
Takayuki KadoyaDepartment of Breast Surgery, Hiroshima University Hospital, Hiroshima University, Hiroshima, Japan.
Masato TakahashiDepartment of Breast Surgery, NHO Hokkaido Cancer Center, Hokkaido, Japan.
Shigenori E NagaiDivision of Breast Oncology, Saitama Cancer Center, Saitama, Japan.
Shoichiro OhtaniDepartment of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.
Tomoyuki ArugaBreast Surgery Division, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
Eiji SuzukiBreast Cancer Unit, Kyoto University Hospital, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Yuichiro KikawaDepartment of Breast Surgery, Kobe City Medical Center General Hospital, Hyogo, Japan.
Hiroyuki YasojimaDepartment of Surgery, Breast Oncology, NHO Osaka National Hospital, 2-1-14 Hoenzaka, Chuou-ku, Osaka, Japan.
Hiroi KasaiInstitute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
Hiroshi IshiguroBreast Oncology Service, Saitama Medical University International Medical Center, Saitama, Japan.
Hidetaka KawabataDepartment of Breast and Endocrine Surgery, Toranomon Hospital, Tokyo, Japan.
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Hironori HagaDepartment of Diagnostic Pathology, Kyoto University Hospital, Kyoto, Japan.
Tatsuki R KataokaDepartment of Diagnostic Pathology, Kyoto University Hospital, Kyoto, Japan.
Ryuji UozumiDepartment of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Shinji OhnoBreast Oncology Center, The Cancer Institute Hospital of JFCR, Tokyo, Japan.
Masakazu ToiBreast Cancer Unit, Kyoto University Hospital, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Kyoto University Hospital · JPKyoto University · JPOsaka National Hospital · JPHiroshima City Asa Citizens Hospital · JPHiroshima University Hospital · JPKanagawa Prefectural Hospital Organization · JPKobe City Medical Center General Hospital · JPSaitama Cancer Center · JPSaitama Medical University · JPThe Cancer Institute Hospital · JPTokyo Metropolitan Komagome Hospital · JPToranomon Hospital · JPUniversity of Tsukuba · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo investigate clinical usefulness of eribulin-based neoadjuvant chemotherapy in triple-negative breast cancer (TNBC) patients.

methodsPatients in group A (aged < 65 years with homologous recombination deficiency, HRD, score ≥ 42, or those at any age with germline BRCA mutation, gBRCAm) were randomized to 4 cycles of paclitaxel plus carboplatin (group A1) or eribulin plus carboplatin (group A2), followed by 4 cycles of anthracycline. Patients in group B (aged < 65 years with HRD score < 42, or aged ≥ 65 years without gBRCAm) were randomized to 6 cycles of eribulin plus cyclophosphamide (group B1) or eribulin plus capecitabine (group B2); non-responders to the first 4 cycles of the eribulin-based therapy received anthracycline. Primary endpoint was pCR rate (ypT0-is, ypN0; centrally confirmed). Main secondary endpoint was safety.

resultsThe full analysis set comprised 99 patients. The pCR rate was 65% (90% CI, 46%-81%) and 45% (27%-65%) in groups A1 and A2, respectively, and 19% (8%-35%) in both groups B1 and B2. No major difference was seen in secondary endpoints, but peripheral neuropathy incidence was 74% in group A1, whereas it was 32%, 22%, and 26% in groups A2, B1, and B2, respectively.

conclusionsIn patients aged < 65 years with high HRD score or gBRCAm, weekly paclitaxel plus carboplatin and eribulin plus carboplatin followed by anthracycline resulted in a pCR rate of > 60% and > 40%, respectively, suggesting potential usefulness of patient stratification using HRD; pCR tended to be low in patients with HRD-negative tumors. Neurotoxicity was less frequent with the eribulin-based regimen.

trial registrationThe study has been registered with the University Hospital Medical Information Network Clinical Trials Registry ( http://www.umin.ac.jp/ctr/index-j.htm ) with unique trial number UMIN000023162. The Japan Breast Cancer Research Group trial number is JBCRG-22.

Indexed as

Breast NeoplasmsTriple Negative Breast NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsCarboplatinFemaleFuransHomologous RecombinationHumansJapanKetonesNeoadjuvant TherapyPaclitaxelPolyether PolyketidesTreatment OutcomeCarboplatineribulinFuransKetonesPaclitaxelPolyether PolyketidesBRCA mutation statusEribulinHomologous recombination deficiency scoreNeoadjuvant chemotherapyPathological complete responseTriple-negative breast cancer

Identifiers

PMID33763789
PMCPMC8233289
OpenAlexW3137349809

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.